Adipose Tissue Allograft for Fat Pad Restoration in Patients at High Risk of Plantar Ulceration

Introduction: The fat pad on the bottom of the foot serves as a shock absorber, protecting underlying tissue during weight-bearing activities. Atrophy or displacement of this fat pad increases plantar pressure on the bones, leading to pain, disability, and possible ulcerations. Reducing pressure is imperative for preventing ulcer formation and recurrence; however, existing treatments are primarily limited to shoe pads. An off-the-shelf cryopreserved human adipose tissue allograft* (CAT), which preserves the native structure and inherent properties of adipose tissue, is designed to reduce pressure via restoration of the fat pad. This case series evaluates the utilization of CAT in patients at risk of developing plantar ulcers.Methods:Diabetic neuropathic patients with pre-ulcerative lesions, such as a callous with subcutaneous hemorrhaging, were selected to receive CAT. Each patient received a subcutaneous implant of 1.5 mL CAT using a 21-gauge needle in the area of a pre-ulcerative lesion during an office visit. Second product administration was at the Investigator’s discretion, typically based on callous development or a large fat pad defect requiring >1.5 mL CAT. The primary outcomes were incidence of plantar ulcers at the site of CAT implantation and adverse events after a minimum of 6-months follow up.Results:Between August and November 2023, 7 male patients, aged on average 71 years (range 57 - 85), with diabetes, neuropathy, and peripheral vascular disease, received CAT implantation. All patients had a history of previous plantar ulcers, with 6 experiencing recurrent ulcerations. CAT was administered once in 3 patients and twice in 4 patients. At the 6-month follow-up (range 6 - 9 months), no ulcerations or treatment-related adverse events were reported, and CAT remained palpable at the site of implantation.Discussion: CAT is a promising approach to manage patients at risk for plantar ulcerations. Long term follow-up for treated patients is ongoing.References: